FDANovember 20, 2015device

FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.

What to do

FDA enforcement status: Terminated

Brands named

depuy mitek inc a johnson johnsondepuydepuy mitek

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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